Avalide Recall

Image via WikipediaBristol-Myers Squibb Co is recalling 60 million tablets of the blood pressure medication Avalide in the United States and Puerto Rico.

The company said it took the action on behalf of the Bristol-Myers Squibb/Sanofi-Synthelabo partnership because of a potential variability in levels of the less-soluble form of the active ingredient in Avalide, irbesartan, which could result in slower dissolution.

Bristol-Myers said 62 lots, or 60 million tablets, manufactured before November 2009 at its plant in Puerto Rico were affected by the recall.

Avalide is comprised of the drugs irbesartan and hydrochlorothiazide. The recalled tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide

From Today: Did Drugmarker Hide Birth Control Patch Risks?

Visit msnbc.com for breaking news, world news, and news about the economy

FTC: Health Claims in Pom Juice Ads Deceptive

Image by bitchcakesny via Flickr The F.T.C. charged Pom Wonderful, which markets the juice, and the company’s owners, the billionaire philanthropists Lynda and Stewart Resnick of Los Angeles, with making false and unsubstantiated claims about the power of their pomegranate elixir.

In a complaint that seeks to prevent the company from making any further medical claims unless they are substantiated by the Food and Drug Administration, the commission said the company ignored evidence that contradicted its claims that the juice could help prevent or treat heart disease, reduce the risk of prostate cancer and overcome erectile dysfunction.

Link: 

FDA warns three companies to stop making unproven claims on mouth rinses

Image via WikipediaThe FDA today issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to, Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action).

These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.

“It is important for the FDA to take appropriate enforcement action when companies make false or unproven product claims to ensure that consumers are not misinformed or misled,” said Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research.

Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter (OTC) drug monograph.
The FDA actions are part of the agency’s effort to curtail an increasing number of Federal Food Drug and Cosmetic Act (FFDCA) violations among the makers/marketers of mouthwashes concerning unproven claims of therapeutic benefits.

To date, the FDA is unaware of any injuries or adverse health effects related to the use of these mouth rinse products. Consumers who have these products may continue to use the products for cavity prevention without risk of injury but should be aware that the FDA has no data to show that these products can prevent gum disease.

Companies that received FDA warning letters are required to take appropriate action to correct these violations within 15 days.  Failure to do so may result in seizure of the product, or other civil or criminal penalties

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm227522.htm

Informal Social Media Group of Attorneys

Guest Post: How Going to Uganda Changed My Perspective

Not law related, from a friend who had a life changing experience:

My Paradigm Shift by Michael G:

For nearly a decade I had heard many stories about the people of Uganda and their amazing spirit and loving attitudes.  My parents relayed their many experiences to me and to the rest of our family. I felt as though I knew our African friends even though I’d never stepped foot on the continent.  I finally had the chance to do that, and it was a trip I almost didn’t take.

Thankfully I eventually came to my senses and realized that life here in the States would certainly go on without me, and that passing up an opportunity to join Jenn (my wife) and both my parents on what I knew would be an amazing and possibly once-in-a-lifetime experience would have been a big mistake.  Little did I know just how true that would be.

No story my mother could have ever told me about the place would have done proper justice to what I learned and witnessed with my own two eyes.  The Ugandan people are wonderful, so caring and welcoming.  The whole experience gave me a newfound perspective on life

We as Americans are constantly bombarded and made so incredibly aware of all that we don’t have, rather than thankful for all that we do. We like to focus on that new gadget or latest “thing” that we feel must have rather than being thankful that we never have to worry about the basic necessities needed to live our day-to-day lives.  Meanwhile, in a place like Uganda – where poverty is the norm – basic necessities: shelter, clothes, food and water to sustain oneself, don’t come so easily.  So the contrast between a culture like ours – where abundance is commonplace – and theirs is quite stark.

This difference in our cultures was evident on our first day at KIDA when we witnessed the joy on the faces of the couple of dozen adults who received our donated tee-shirts.

And that wasn’t anything compared to the reactions we got from the children after we handed out some pencils.  It’s hard to imagine a child in this country getting very excited about a seemingly insignificant give-away, but not so in Uganda.  It immediately made me feel really good to know that what we do for these people, even when it’s small, is so appreciated.

What made the trip for me was not just being there to give away a few freebies.  That sort of thing can only get you so far.  No, it was witnessing first-hand all of the truly empowering and self-sustaining programs KIDA is able to provide to the people in the rural Kitojo community–-programs made possible with donations from the Friends of Ruwenzori.

Reverend Ezra, the founder and director of KIDA whom I finally had the great pleasure of meeting and spending time with, is a tremendous leader and visionary.  He, with great wisdom, subscribes to the theory that giving a man a fish accomplishes little more than to satisfy his appetite that day….for he will be hungry again tomorrow as well.  And creating a dependency on handouts serves no one in the long run.  But instead Ezra’s knows that teaching the man or woman the skills to fish will help him sustain himself for many days to come.  That philosophy is quite prevelent at KIDA and can be seen through all the wonderfully impactful vocational programs being taught on a daily basis.

Having witnessed so much of the important work being done by KIDA makes me feel really good about the role we are playing in supporting their efforts through our Friends of Ruwenzori donations.  I also saw, during my time in Uganda,  just how much can still be done.  KIDA is making a huge difference in their community, and they’re doing it the right way through noble works and with true accountability. But so much more can be done.  And so much more needs to be done.  Only a certain number of people can be helped on a limited budget, and that is precisely why we must continue to do our part to expand this model organization as much as possible.  I urge everyone who has the means to help. So please do what you can.  Giving has been quite sparse this year and my mother is worried that KIDA’s programs will suffer. 

If you choose to visit KIDA in person one day, I know you will be amazed at the work being done in this remarkable community. I believe you will also notice changes in how you view the opulence of our American society, as I did.  You will see how handouts can create dependency, but how training empowers the poor to take care of their own lives.  I was so inspired to see this happening in Africa.

Well done Mike.

Friends of Ruwenzori Foundation • c/o Karen and Gil Gleason • 8 Altamount Drive • Orinda, CA 94563
gilgleason@comcast.net • (925) 376-0519 •  www.friendsofruwenzori.org

Image via WikipediaHalf of the 21 drugs pulled from the market in the U.S. for safety reasons since 1995 involved heart complications.



The drugs recalled since 1995 because of heart risks include Roche Holding AG’s blood-pressure treatment Posicor in 1998, Johnson & Johnson’s antihistamine Hismanal in 1999, and Merck & Co.’s painkiller Vioxx in 2004. The average time to recall was 8 years, according to data compiled by Bloomberg.


Vioxx, used to treat arthritis, was recalled by Whitehouse Station, New Jersey-based Merck after five years of marketing when a study suggested the drug doubled the risk of heart attacks after 18 months of treatment. An earlier study published in 2000 suggested the medicine posed heart risks and led to calls for further research into the drug’s side effects.

Avandia, once the world’s best-selling diabetes drug, was linked to a 43 percent higher risk of heart attacks in an analysis released in 2007, eight years after its approval. Glaxo, of London, said last week that it would stop promoting the drug as a result of new FDA restrictions and European regulators’ decision to withdraw the product completely.

Meridia, a 13-year-old diet pill, was tied to 16 percent more major cardiovascular complications in a six-year study of 10,000 patients released this month. Abbott Park, Illinois-based Abbott no longer promotes the drug in the U.S.


Read more here:http://www.bloomberg.com/news/2010-09-28/recalled-drugs-tied-to-heart-risk-spurs-call-for-fda-review.html

Why the EU banned Avandia but the FDA Didn't

From Fortune and CNN/Money:


Avandia has taken some beatings over the years, but it pretty much took a fatal blow yesterday. That's when the Food and Drug Administration ruled to keep the drug on the market in the United States with some serious restrictions.
Those being: GlaxoSmithKline (GSK), the drug's manufacturer, can't promote it. Patients currently on the drug will be advised to switch to another similar treatment, if possible. Doctors can't prescribe Avandia to new patients without explaining in detail why it might be more likely to cause a heart attack than other options. The FDA basically mandated everything short of putting a skull and crossbones on the label. But here's the rub: The European Union's European Medicines Agency dispensed with the subtleties and outright banned Avandia from being sold. Why didn't the FDA?

For more go here.  http://money.cnn.com/2010/09/24/news/companies/FDA_Avandia_GSK_ban.fortune/index.htm?section=money_latest&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%253A+rss%252Fmoney_latest+%2528Latest+News%2529

Abbott Voluntarily Recalls Certain Similac® Brand Powder Infant Formulas

Image by The Consumerist via FlickrAbbott is initiating a proactive, voluntary recall of certain Similac-brand, powder infant formulas in the U.S., Puerto Rico, Guam and some countries in the Caribbean.Abbott is recalling these products following an internal quality review, which detected the remote possibility of the presence of a small common beetle in the product produced in one production area in a single manufacturing facility. The United States Food and Drug Administration (FDA) has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae, could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract. If these symptoms persist for more than a few days, a physician should be consulted.
The recall of these powder infant formulas includes:

• Certain Similac powder product lines offered in plastic containers.
• Certain Similac powder product lines offered in sizes such as 8-ounce, 12.4-ounce and 12.9-ounce cans.

To immediately find out if the product in your possession is included in this recall, parents and caregivers should visit www.similac.com/recall⁹, and type in their lot number to determine if their product is affected, or call (800) 986-8850.
No Abbott liquid infant formulas are impacted. Products not involved in the recall include all Abbott Nutrition liquid ready-to-feed and concentrated infant formulas and all powder and liquid specialty formulas, such as Similac Expert Care™ Alimentum®, Elecare®, Similac Expert Care™ Neosure®, Similac® Human Milk Fortifier, and metabolic formulas for inherited disorders.
About the Recall

• The company is implementing a plan to address this matter in the affected manufacturing facility, which is expected to be completed shortly. No other facilities or products are involved in this recall.
• Abbott has consulted with the U.S. FDA regarding this recall.

Panel asks if FDA knew about Secret J&J recall

Image via Wikipedia
From Reuters:


The House Committee on Oversight and Government Reform on Tuesday said it had obtained an email in which an executive of J&J's McNeil consumer medicines unit described an agreement with the  FDA authorizing J&J to conduct an unpublicized recall of adult Motrin.

The committee said the agreement purportedly allowed McNeil to forgo a publicly announced formal recall of the Motrin product and to instead conduct a "soft market withdrawal." The committee for months has been examining what it describes as the "phantom recall" of Motrin, in which contractors quietly bought up stocks of the painkiller from store shelves.

The committee on Tuesday released a copy of a May 27, 2009, email from a McNeil executive to numerous colleagues, which cites a negotiated agreement with the FDA consenting to an unofficial recall of Motrin.
"This was a major win for us as it limits the press that will be seen," the email said, adding the company had promised the FDA to complete the informal recall by July 15.

Read more here http://www.reuters.com/article/idUSTRE68K5K020100922

IPhone: Florida Law App

Image by TerryJohnston via Flickr
I just ran across the Florida laws application for the iPhone from www.legalmesh.com.


It's worth a look From the site:

Search the statutes the way you want - keyword, statutory language, or browse the chapters to reach what you need. If you know where you want to go, just type in the chapter or section to jump right there. Get to the statute you need quickly and intuitively.

Symbiq One- and Two-Channel Infusers Recalled

Symbiq One- and Two-Channel Infusers manufactured by Hospira are subject to a class 1 US Food and Drug Administration (FDA) recall because of a potential for the failure to detect air in the line at the end of an infusion. An alert sent September 10 from MedWatch, the FDA's safety information and adverse event reporting program, indicates that the recall was initiated on April 9, 2010, and affects model number 16026 Symbiq One-Channel Infuser and 16027 Symbiq Two-Channel Infuser.


The manufacturer mailed an updated clinical bulletin on June 11, 2010, which stated that the user does not have to remove or stop using the Symbiq infusion pump, and it provided recommended mitigation actions such as not running solution/medication containers dry and programming the pump for 95% of stated volume of container (minus the priming volume) or less.

To date, no reports of serious injuries have been received, but the manufacturer states that "failure to detect air in line may result in the delivery of air to the patient, resulting in serious injury or death.

Miracle Mineral Solution (MMS) Warning

Image via WikipediaThe U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.
Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary. 

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.


The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.

Georgia: Dupuy Hip Implant Recall:

Image via Wikipedia

Thousands of patients left in agony by faulty hip replacements

 Tens of thousands of patients are being recalled to hospital because of a faulty hip implant that has caused tumours, tissue erosion and a build up of metal debris.

Orthopaedic surgeons across the UK will see around 8,000 patients in the coming weeks to determine how many are affected. Dozens of British and Irish patients are suing the company DePuy after being forced to undergo second hip-replacement operations because of pain and disability.

Hundreds more could follow suit, as, at 13 per cent, the failure rate for the ASR metal resurfacing implants is three times higher than for similar products on the market. Around 1,000 patients in England and Wales have already had remedial hip replacements. 

Link

 

 

 

FDA Relents from Midodrine Recall

Image via WikipediaFederal regulators have backed off a plan to remove a Shire PLC low blood-pressure treatment from the market after warning in August that the drug has not been proven effective.
Food and Drug Administration representative Sandy Walsh said in an emailed statement that the agency will continue to allow access to ProAmatine, also known as midodrine, "while the necessary data is collected and the legal issues get sorted out."

Roughly 100,000 U.S. patients received prescriptions for ProAmatine or generic versions last year, according to the FDA. The drug is approved to treat orthostatic hypotension, a type of low blood pressure that causes patients to become dizzy or faint when standing upright.

Last month, the FDA proposed withdrawing the drug from the market and giving Shire, which is based in Ireland, an opportunity to schedule a hearing to discuss the matter. It had approved ProAmatine in 1996 based on promising early results in treating low blood pressure. But a mandatory follow-up study to actually prove the long-term benefits of the drug was never conducted.

Shire acquired the drug when it bought Roberts Pharmaceuticals in 2000. Shire spokeswoman Jessica Mann said the drugmaker did conduct follow-up trials and submitted data in 2005 that it believes showed its effectiveness. The company plans to continue to work with the FDA. Shire had said it was planning to withdraw the drug from the market by Sept. 30. But the company no longer intends to do so.

Source. 

No Class Action for Zyprexa

A federal appeals court in New York threw out a September 2008 ruling by Judge Jack B. Weinstein of United States District Court in Brooklyn. The Judge had ruled that the plaintiffs could pursue as a group claims that Lilly’s Zyprexa marketing caused them to pay more for the drug than it was worth. The plaintiffs were seeking $6.8 billion in damages.

Judge Weinstein had ruled in favor of the unions, pension funds and insurance companies, known as third-party payers, rejecting Lilly’s argument that their claims were too different to be tried together. The appeals court reversed that decision, finding that the link between marketing Zyprexa to doctors and the injury claimed by the payers was “attenuated.”

“Crucially, the third-party payers do not allege that they relied on Lilly’s misrepresentations — the misrepresentations at issue were ‘directed through mailings and otherwise at doctors,’ ” the appeals court said.

Source: http://www.nytimes.com/2010/09/11/business/11drug.html?_r=1&partner=yahoofinance

Effexor: No Preemption in pending Litigation

 Judge John Fullam (Eastern District of Pennsylvania) denied Wyeth’s preemption-based summary judgment motion in a number of Effexor SSRI suicide cases pending in USDCT.

Baumgardner

View more documents from mzamoralaw.

Quote:  "Wyeth has filed a motion for summary judgment arguing that the plaintiffs’ state-law tort claims must be dismissed as preempted by federal law.  the narrow issue for the Court is whether the defendant has presented “clear evidence that the FDA would not have approved a change to [the drug’s] label"



The Court held:  In sum, the defendant has not shown that the FDA would
not have approved a change to Effexor’s label.

Sulindac: SJS Verdict for Woman harmed by this drug

Image via WikipediaA federal jury in New Hampshire has awarded $21 million to a woman blinded and scarred by a prescription drug she took for shoulder pain.

K. Bartlett Plaistow suffered extreme burns to her skin, mucus membranes and eyes after taking the anti-inflammatory drug Sulindac. After three days of deliberations, the jury found Wednesday that Philadelphia-based Mutual Pharmaceutical Co. was liable for her injuries and should have known the drug was unreasonably dangerous to consumers.


Bartlett said her goal in filing the lawsuit was to educate others about the dangers of prescription drugs.
"That was my biggest thing — getting the word out," Bartlett said. "Before this happened to me, I never knew something like this could happen just from taking medication."

Bartlett began taking Sulindac in January 2005 to treat shoulder pain. Two weeks later, she noticed red spots on her face and irritation around her eyes. She was admitted to the hospital on Feb. 2, 2005, complaining of feeling like there were "pebbles" under her eyelids and in her throat, and suffering from a worsening rash.

She was diagnosed as having Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN) — potentially fatal skin diseases that inflame the mucus membranes and eyes and are marked by a skin rash that burns off the outer layer of skin. She spent 112 days in five hospitals, including the Massachusetts General Hospital Burn Unit. The disease also seared her throat, stomach and lungs, causing permanent disabilities.

About SJS:

SJS usually begins with fever, sore throat, and fatigue, which is misdiagnosed and usually treated with antibiotics. Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips but also in the genital and anal regions. Those in the mouth are usually extremely painful and reduce the patient's ability to eat or drink. Conjunctivitis of the eyes occurs in about 30% of children who develop SJS. A rash of round lesions about an inch across arises on the face, trunk, arms and legs, and soles of the feet, but usually not the scalp.

In Stevens-Johnson syndrome, a person has blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. In toxic epidermal necrolysis, there is a similar blistering of mucous membranes, but in addition the entire top layer of the skin (the epidermis) peels off in sheets from large areas of the body. Both disorders can be life threatening.

Nearly all cases are caused by a reaction to a drug, most often sulfa antibiotics; barbiturates; anticonvulsants, such as phenytoin ome
   

Some cases are caused by a bacterial infection. Occasionally, a cause cannot be identified. The disorder occurs in all age groups but is more common among older people, probably because older people tend to use more drugs. The disorder is also more likely to occur in people with AIDS.

http://www.google.com/hostednews/ap/article/ALeqM5gsSPXfpgvOeZdcMxjDTqOyQVGWRAD9I407KO0

Georgia News: Avandia in the UK

The diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) is once again in the media spotlight  in the UK, where it has emerged that experts from the UK Commission on Human Medicines (CHM) decided unanimously at the end of July that the drug should be withdrawn.


This recommendation was not made public, however, in line with protocol. It was communicated to the British drug-licensing agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), which instead sent out "Dear doctor" letters reiterating safety information with regard to rosiglitazone from 2007, including a suggestion to consider alternative treatments where appropriate.

http://www.theheart.org/article/1120105.do

En Espanol:


El rosiglitazone de la droga de la diabetes (Avandia, GlaxoSmithKline) es una vez más en los medios ilumina con proyector en el RU, donde ha surgido que expertos de la Comisión del RU en Medicinas Humanas (CHM) decidió unánimemente a fines de julio que la droga debe ser retirada. 

Gardasil Dangers ?

Image via Wikipedia

Gardasil and Cervarix are similar drugs promoted as a cervical cancer vaccine.

 
The drugs vary in the types of human papillomavirus (HPV) they treat, which is the virus said to cause cervical cancer. Gardasil, manufactured by Merck, Inc.,  is promoted as the only cervical cancer vaccine that helps protect against four kinds of HPV (types 6, 11, 16 and 18), including two types that cause 70 percent of cervical cancer cases, and two more types that cuase 90 percent of genital warts cases.
Cervarix, manufactured by GlaxoSmithKline,  is not currently available in the United States, but was approved for use in the U.S. by the FDA on October 16, 2009, and is expected to enter the market here by late 2009. It is already approved for use in Australia, the Phillipines and the European Union. It is used in the UK for a national program of vaccination for teen and pre-teen girls to target two types of HPV (types 16 and 18) for the prevention of cervical cancer and pre-cancers.

Both Gardasil and Ceravix are marketed to be given to girls and young women as young as age 9, and up to age 26.

Since Gardasil’s introduction in 2006, the Vaccine Adverse Event Reporting System (VAERS) has received more than 15,000 reports of adverse side effects related to Gardasil. These reports include serious adverse 
side effects including Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. There also have been 44 reported deaths as a result of Gardasil uses.

Cervarix has been linked to more than 2,000 cases of serious, adverse reactions since the UK government began administering it to schoolgirls last year. One of the worst cases involved 14-year-old Natalie Morton, who collapsed and died in school in England just one hour after receiving the vaccine.

Then, on October 25, 2009, Dr. Diane Harper, lead researcher in the development of two human papilloma virus (HPV) vaccines and director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, told an audience of medical professionals that Gardasil is largely unnecessary, and that it has never been fully tested on females under the age of 15. This, despite strong marketing efforts to make the drug mandatory for girls, and product literature and advertising that state the product can be used by girls as young as age 9.

On Oct. 16, 2009, the same day GlaxoSmithKline got approval to market its Cervarix drug in the U.S. the FDA also granted approval to Merck to expand the use of Gardasil in the U.S. to treat boys and men ages 9-26 for the prevention of genital warts.

Ad in the United States, and is recommended for girls and women ages 9-26 by manufacturer Merck, Inc.

In February 2009, the National Vaccine Information Center, a private vaccine-safety group, conducted a comparative study of adverse events reported following a Menactra (meningococcal) vaccine versus the Gardasil vaccine.  Both vaccines are recommended for youngsters in the same age group, at 11-12 years old (Menactra for boys and girls, Gardasil for girls only). The study compares VAERS data reported for each vaccine.

The study found that Gardasil is associated with at least twice as many Emergency Room visit reports, four times more death reports, five times more “did not recover” reports, and seven times more “disabled” reports, as compared to Menactra.
Other findings of this study show that compared to Menactra:

• Gardasil is associated with all reports of blood clots
• Gardasil is associated with at lest four times as many cardiac arrest reports
• Gardasil is associated with at least six times as many fainting reports
• Gardasil is associated with at least four times as many Lupus reports
• Gardasil is associated with at least 15 times as many stroke reports

Generic Keppra Update

A generic version of the anti-convulsant medication Keppra, commonly used to treat patients that suffer from seizures, such as epileptics, was approved by the U.S. Food and Drug Administration (FDA) for marketing in 2009. However, it seems that patients who switch from Keppra to the generic, Levetiracetam, are experiencing increased re-occurance of seizures after having been seizure-free on the brand name Keppra.

Patients who were switched from Keppra to generic Levetiracetam may suffer economic losses resulting from having their driving privileges revoked because of seizure danger, inability to work, unable to attend school, and other problems. Additionally, there have been reports of injuries and at least one death resulting from a patient who suffered a seizure and died after being switched from Keppra to the generic drug.

In addition to treating patients with epilepsy or other seizure disorders, Keppra or Levetiracetam may be administered to patients who have had a traumatic brain injury (TBI) and had seizures from their brain injury.

Generic Keppra is made by a number of different manufacturers:

Aurobindo Pharma
Cobalt Pharmaceuticals
Dr. Reddy's Laboratories
Mylan Pharmaceuticals
Roxane Laboratories, Inc.
Sandoz
Teva Pharmaceuticals
Generic Keppra tablets are available in the following strengths:

Levetiracetam 250 mg
Levetiracetam 500 mg
Levetiracetam 750 mg
Keppra oral solution (liquid) is also available in generic form.

All generic medications must undergo certain tests to compare them to brand-name medications. The FDA then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns each generic a rating.

An "AB" rating means that the FDA has determined that a generic medication is equivalent to a brand-name medication. All of the generic Keppra versions currently available have an "AB" rating, meaning they should be equivalent to Keppra.

However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers or dyes or other ingredients that may cause problems for people with allergies or sensitivities.

It should also be noted that many health care providers believe that special care should be taken when switching a patient from a brand-name seizure medication to a generic one, or even switching between different generic versions of a medication.

ROP and ETROP: The Seminal Study about ROP

My office has worked on cases involving ROP in young children. I get asked about what might be the best source for information and to me it's the ETROP study.


At age 5 1/2 years, the oldest age for which follow-up data are available, children with threshold ROP who were enrolled in the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) -- Outcome Study showed fewer treated eyes (31.5 percent) than control eyes (48 percent) that were blind (P<0.001). of those eyes that had a favorable structural outcome, with or without retinal ablation (cryotherapy to destroy the fringe of the retina through freezing), only a small percentage had best corrected visual acuity better than or equal to 20/40 at age 5 1/2 years (13 percent in the treated group; 17 percent in the untreated control group (p=0.19)). among the 1398 followed from the 5 large natural history centers of the cryo-rop follow-up study, children with retinal residua of rop (structural changes) had measurable visual acuity that was severly affected and tended to worsen with age. the cryo-rop study proved conclusively that peripheral retinal ablation improves the chances of avoiding blindness, but at least 80 percent of eyes are left with acuity less than 20/40.

Two concerns emerged from the CRYO-ROP extensive study on the natural history of ROP and treatment of threshold ROP. The first of these is failure of peripheral retinal ablation to eliminate all, or nearly all cases, of retinal detachment due to ROP. In the CRYO-ROP Study, 26 percent of eyes with threshold disease in zone II and 78 percent of eyes with zone I threshold disease had an unfavorable structural outcome despite treatment. The second concern is that most children who developed threshold ROP disease had visual acuity worse than 20/40 even if the eye had a favorable structural outcome.

Since no other treatment has yet been shown to be effective in preventing blindness from ROP, retinal ablation remains the treatment of choice. The ETROP Study will test whether earlier treatment is more effective than treatment at threshold in improving functional (visual acuity) outcome following ROP, as well as determining whether earlier treatment decreases the probability of an unfavorable structural outcome.

Description

Earlier treatment is defined as retinal ablation administered to the avascular retina when an eye reaches high risk prethreshold retinopathy of prematurity (ROP). Prethreshold indicates any Zone I ROP; or Zone II stage 2 with plus disease, or stage 3; or Zone II with less than 5 contiguous or 8 cumulative clock hours of stage 3 ROP with plus disease. Recognizing that a substantial number of eyes undergo spontaneous resolution of ROP, eyes will be randomized to early treatment only when high risk for an unfavorable visual acuity outcome is identified. High risk will be determined using a risk model analysis program based on longitudinal natural history data obtained from the CRYO-ROP study. This model integrates risk factors to assign a risk of progression to blindness without treatment. These factors include birth weight, gestational age, ethnicity, singleton/multiple status, outborn status, Zone on first exam, severity of ROP and rate of progression of ROP. When an infant develops prethreshold ROP and greater than or equal to 15 percent risk of unfavorable outcome, randomization to early treatment of one eye will occur. Visual acuity outcome will be measured by masked observers after wearing best corretion using the Teller Acuity Card Procedure at 9 months corrected age.

Patient Eligibility

Infants <1251 grams birthweight born at participating centers and/or examined by 42 days of life are eligible. the early treatment trial requires that an infant have prethreshold retinopathy of prematurity (rop).

Patient Recruitment Status

Completed. A total of 317 infants with birth weights less than 1251 g and birth dates between October 1, 2000, and September 30, 2002, were enrolled at 26 participating centers.
Grating acuity results showed a reduction in unfavorable visual acuity outcomes with earlier treat-ment, from 19.5% to 14.5% (P = .01). Unfavorable structural outcomes were reduced from 15.6% to 9.1% (P<.001) at 9 months. further analysis supported retinal ablative therapy for eyes with type 1 rop, defined as zone i, any stage rop with plus disease (a degree of dilation and tortuosity of the posterior retinal blood vessels meeting or exceeding that of a standard photograph); zone i, stage 3 rop without plus disease; or zone ii, stage 2 or 3 rop with plus disease. the analysis supported a wait-and-watch approach to type 2 rop, defined as zone i, stage 1 or 2 rop without plus disease or zone ii, stage 3 rop without plus disease. these eyes should be considered for treatment only if they progress to type 1 or threshold rop.

Early treatment of high-risk prethreshold ROP significantly reduced unfavorable outcomes to a clinically important degree. Additional analyses led to modified recommendations for the use of peripheral retinal ablation in eyes with ROP. Long-term follow-up is being conducted to learn whether the benefits noted in the first year after birth will persist into childhood.

OTHER OCULAR AND CLINICAL FINDINGS
The distribution of refractive errors at the 9-month examination was similar between the high-risk prethreshold eyes that received early treatment and those that were conventionally managed.
Cataract or aphakia that was not associated with total retinal detachment or vitrectomy was found in 4 eyes (1.2%) in the group treated at high-risk prethreshold and 4 eyes (1.2%) in the conventionally managed group. Nystagmus occurred in 22% of randomized infants with bilateral high-risk ROP.

  A table ompares other ocular and systemic complications of treatment among infants treated at high-risk prethreshold vs conventionally managed infants in whom high-risk prethreshold ROP progressed and who later underwent treatment at threshold. Ocular complication rates were similar in the 2 groups. Systemic complications were higher following treatment at high-risk prethreshold. Infants with high-risk prethreshold ROP who were randomized to early treatment received peripheral retinal ablation at a mean postmenstrual age of 35.2 weeks compared with 37 weeks in conventionally treated infants who underwent peripheral retinal ablation at threshold.

http://www.nei.nih.gov/neitrials/static/study83.asp

Grassley seeks answers to USDA's role at egg farms

Sen. Charles Grassley has asked Agriculture Secretary Tom Vilsack to address accusations that federal workers ignored complaints about conditions at an Iowa farm involved in a recall of salmonella-tainted eggs.
Grassley sent a letter to Vilsack on Tuesday, asking whether the U.S. Department of Agriculture had received complaints and was what done to investigate the concerns. He also asked Vilsack whether there is a system in place for farm and USDA employees to report problems.

"The recent egg recalls ... have troubled consumers and weakened confidence in our nation's food supply," Grassley wrote in the letter. "When Americans visit their local grocery store, they should be able to trust that the food they are purchasing to feed their family is safe to consume."

The Iowa senator said his questions arose after two former workers at Wright County Egg near Galt, Iowa, claimed they complained about problems at the farm to USDA employees working there but were ignored.
USDA spokesman Caleb Weaver said Wednesday that the agency is working on a response to Grassley's letter.

Last week, Weaver said a USDA employee who oversaw agency operations at the farm did not recall any concerns being raised but the agency was continuing its investigation into the claims.
On Wednesday, Weaver said he did not have any additional information about the situation.
USDA employees at the farm inspect eggs and grade them but are not there to inspect for food safety issues. An agreement with the Food and Drug Administration does allow them to report unsanitary or other conditions that would require them to withhold the voluntary grading service.

Source. 

U.S. court orders Teva to pay $365m to Hepatitis C-infected man

Image via CrunchBaseTeva Pharmaceutical Industries and Baxter Healthcare Services on Friday were ordered to pay  punitive damages to a Nevada man who contracted Hepatitis C during an outbreak two years ago.

The Clark County District Court jury in Nevada ordered Teva to pay $356 million and Baxter to pay $144 million in the largest jury award in Nevada history.

Henry Chanin and more than 100 others claimed to have contracted the liver disease Hepatitis C after the anesthetic propofol were reused for colonoscopy or endoscopy procedures. Teva made the drug and Baxter distributed it according to the lawsuit.

Teva said it continues to believe that the evidence shows the company acted responsibly. The label for its propofol product clearly states that it is for single patient use only and that aseptic procedures should be used at all times.

Source

Canada Dry gets warning about Green Tea Beverages

Image via WikipediaFederal health regulators have issued warnings to the makers of Canada Dry ginger ale and Lipton tea for making unsubstantiated nutritional claims about their green tea-flavored beverages.

In a warning letter issued Aug. 30, the Food and Drug Administration takes issue with the labeling of Canada Dry Sparkling Green Tea Ginger Ale. The agency issued a similar letter Aug. 23 to Unilever Inc., over website and product labeling for its Lipton Green Tea.

Food processors increasingly have been adding vitamins and nutrients to their products to make them more appealing to health-conscious consumers. But the FDA letter to Dr. Pepper Snapple Group, which makes Canada Dry, states that the agency “does not consider it appropriate to fortify snack foods such as carbonated beverages.”

More here. 

Accutane Verdict Reversed

A judge  has ordered a 10.5 million dollar  Accutane verdict overturned "because the original verdict followed from an unfair trial.




During the trial Roche, the maker of Accutane, was not allowed to present evidence regarding how many people used Accutane until the final stages of the trial.

The New Jersey Appellate Court ruled that Roche did not have "a full and fair opportunity... to present and advocate the relevant numbers evidence," Bloombery reports.

The trial court in the case, Kendall v. Hoffmann LaRoche Inc., had entered a verdict of $10.5 million in favor of a woman that claimed the drug Accutane caused her inflammatory bowel disease (IBD) . In the 2008 trial, the jury found that Roche failed to adequately warn Kamie Kendall about the gastrointestinal risks associated with Accutane use. The makers of Accutane, Roche Holding AG, have been sued on multiple occassions over claims that the drug causes IBD.

http://blogs.findlaw.com/decided/2010/08/105m-accutane-verdict-overturned.html

Georgia Avandia: News of Problems in Forums/Chat Rooms as early as 04?

Image by neofedex via Flickr
A new report says patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk. Neither physicians nor company officials acknowledged their worries, contributing to an alarming drop in patient sentiment and, according to authors, a lost opportunity to reach out and restore trust.

Patients first started questioning whether it was safe to take Avandia given their situation, especially those with congestive heart failure (CHF), in 2003 and 2004, but the drug was still seen as a good alternative for many with type 2 diabetes, notes the report. Negative comments began referencing Avandia risks in 2005 but were more likely to grow out of frustration with weight gain and edema—potential side effects of drugs in the thiazolidinedione (TZD) class.

The tone changed in 2006. Discussions went beyond swelling and weight gain to comparisons with other products shown to lower blood sugar without these risks, such as Eli Lilly/Amylin's Byetta and Merck's Januvia. Chatter about other side effects lit up message boards, as well. Analysis of comments shows patients connected edema to an increased risk of CHF, and some reported increased blood pressure. Anger and frustration grew, as physicians seemed disconnected from the concerns.


More here

New Design for the Blog

So, what do you think? I am playing around with some new themes. It's been nearly 4 years since any change - bear with me as I trudge through this stuff.



Like? Dislike? email me galawyerblog(at)yahoo.com 

Huber Needle Recall

Image via WikipediaThe US Food and Drug Administration (FDA) has issued 2 class 1 recalls of Huber needles due to cases of coring when inserted into ports. "Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core travelling through blood vessels into the patient's lungs. These issues may potentially cause death," the FDA announced.


The recalls include certain models and lot numbers of 22 Gauge x 1" straight Huber needles and 22 Gauge Right Angle x 1" Huber needles. The needles were distributed by Navilyst as a component of Vaxel Implantable Port Systems, some of which may have Boston Scientific labeling. A full list of the product codes and lots numbers subject to the recalls is available at on the FDA's Web site.

According to the FDA, more than 54,000 units distributed between May 2, 2007, and May 1, 2010, are included in the recalls. An alert was issued yesterday as a part of an ongoing investigation after testing in September and November 2009 detected cores in 2 lots of Multi-Med needles. Cores were seen in an estimated 23% to 86% of the sample lots.

Source

GERD in Infants

It is common for infants to spit up after a meal, but frequent vomiting among infants may be caused by GERD (gastroesophageal reflux disease).

Definition:
It refers to immaturity of lower esophageal sphincter function, manifested by frequent transient lower esophageal relaxations that results in retrograde flow of gastric contents into the esophagus.
Gastroesophageal reflux is classified as follows:

Physiological reflux: These patients have no underlying predisposing factors or conditions. Growth and development are normal, and pharmacologic treatment is typically not necessary.
Pathological reflux or gastroesophageal reflux disease (GERD): Patients frequently experience complications , requiring careful evaluation and treatment.

Secondary gastroesophageal reflux: This refers to a case in which an underlying condition may predispose to gastroesophageal reflux. Examples include asthma (a condition which may also be, in part, caused by or exacerbated by reflux and gastric outlet obstruction.


More here.

Meridia and Heart Problems?

The New England Journal of Medicine (NEJM) has found that among nearly 10,000 overweight or obese patients, those who used Meridia had a 16% greater risk of having a heart attack or stroke over an average 3.4 years than patients taking a placebo. None of the events were fatal, but the finding was especially worrisome since the trial included only patients with a previous history of heart disease or diabetes, or both, which put them at high risk of a second event. Being overweight, they were also already at a higher risk of heart-related health problems.


A study was commissioned by the European Union's European Medical Agency, after initial studies of Meridia users, conducted prior to 2002, found that the drug raised blood pressure and pulse rates, both well known risk factors for heart disease. When Meridia, which suppresses appetite by regulating the brain chemicals serotonin and norepinephrine, was approved for use in the U.S. in 1997, the FDA included a warning about these risks on the label.

Read more: http://www.time.com/time/health/article/0,8599,2015619,00.html#ixzz0yKq0tzz1

Read more: http://www.time.com/time/health/article/0,8599,2015619,00.html#ixzz0yKprSrjQ

Georgia: FDA Recalls DePuy Hip Implants

After receiving complaints about the product, orthopedic manufacturer DePuy has issued a recall of its ASR hip implants. This hip system has a shockingly high rate of failure, and many of the victims of these failures have had to undergo a second, painful surgery to remove and replace the defective hip.

Due to a fairly high percentage (12-13%) of five year revision or secondary hip surgeries DePuy Orthopaedics, Inc. reported based on this year's data from the National Joint Registry (NJR) of England and Wales, the manufacturer announced this week it is voluntarily pulling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System from the marketplace. DePuy has notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally of the voluntary recall.

The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices preferred by surgeons for young patients who may benefit from the stability of the device, thus limiting the chance of repeated dislocation. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide.

The risk for revision was highest with women utilizing ASR head sizes below 50 mm in diameter.

As the numbers suggest, most ASR hip replacement surgeries are successful. However, Depuy is strongly suggesting patients utilizing an ASR device immediately see their implant surgeons for a full evaluation of performance.

Prempro Case on Breast Cancer Settles Before Retrial

From Bloomberg:

Pfizer agreed to settle an Arkansas woman’s claims that the company’s Prempro menopause drug caused her breast cancer this week.

There was to be a retrial on October 1st of Donna Scroggin’s claims that the company should pay as punishment for the damage that Prempro, a hormone-replacement medicine, caused. An appeals court overturned a $27.1 million punitive award last year and ordered a new trial on damages.

The company agreed to settle Scroggin’s case, U.S. District Judge William Wilson said in an Aug. 19 court filing.

En Espanol:

Pfizer acordó resolver las demandas de una mujer de Arkansas que las drogas de la empresa la menopausia Prempro le causó el cáncer de mama esta semana.

No iba a haber un nuevo juicio el 1 de octubre de reclamaciones Donna Scroggin de que la empresa debe pagar como castigo por el daño que Prempro, un medicamento de reemplazo hormonal, causado. Un tribunal de apelaciones anuló un laudo 27,100,000 dólar punitiva del año pasado y ordenó un nuevo juicio por daños y perjuicios.

La empresa de acuerdo para resolver el caso de Scroggin, EE.UU. El juez de distrito William Wilson dijo en una presentación 19 de agosto la corte